in Tag: Safety And Performance  (clear all)


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Medical Devices and IVDs - Essential Principles of Safety and Performance (MCC: 8.02, Jul 2016)

Medical Devices and IVDs - Essential Principles of Safety and Performance

Related Tags (New Search): Medical devicesIVDsSafety and performanceApplication

Guideline on Preclinical Safety Studies for Veterinary Medicines (MCC: 3.05, Jan 2004)

Guideline on Preclinical Safety Studies for Veterinary Medicines. Secular 3.05

Related Tags (New Search): Safety and performanceGCPVeterinary medicine

Safety of Veterinary Biologicals (MCC: 3.08, Jan 2004)

This guideline provides information on the safety aspects of veterinary biological medicines. Circular 3.0 H

Related Tags (New Search): Biological medicinesSafety and performanceSafetyVeterinary medicine

Conformity assessment procedures – medical devices and IVDs (MCC: 8.03, Sept 2016)

Conformity assessment procedures – medical devices and IVDs

Related Tags (New Search): Medical devicesIVDsSafety and performanceApplicationQuality

Guideline on Veterinary Drug Adverse Events (MCC: 3.09, Jan 2004)

This guideline provides information on the reporting and management of adverse events with veterinary medicines. Circular 3.09

Related Tags (New Search): Safety and performanceRecallsVeterinary medicine

Complementary Medicines – Health Supplements Safety and Efficacy (MCC: 7.04, Jun 2016)

This guideline provides information required for the application for registration of health supplements. The guideline provides details on compliance with GMP, GLP and good agricultural and collection practices. It also provides the format for the presentation of administrative information, common…

Related Tags (New Search): Health supplementsVitamins & MineralsSafety and performanceApplicationEfficacyCTD

Guidelines for a Licence to Manufacture, Import Export or Distribute Medical Devices and IVDs (MCC: 16.03, July 2016)

Recommendations or licensing requirements for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): GMPIVDsLicencingMedical devicesClassification Conformity assessmentSafety and performanceFeesClassificationImportersDistributor

Complementary Medicine – Discipline-Specific Safety and Efficacy (MCC: 7.01, Jun 2016)

This guideline provides information for applicants wishing to submit applications for the registration of complimentary medicines. It includes information on the format of submission, technical details on the types of substances and preparations, naming of substances and ingredients, multicomponent formulations…

Related Tags (New Search): Complementary medicinesHealth supplementsAyuvedicUnani TibbChinese traditionalSafety and performanceEfficacy